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Anxious Undertones: A Review of 2019

Dec 17, 2019, 11:40 AM by Michael Barbella

Despite a healthy U.S. economy and solid corporate growth, the medtech industry was wracked with worries in 2019.

Michael Barbella, Managing Editor

Things are not always what they seem; outward form deceives many; rare is the mind that discerns what is carefully concealed within.” — ”The Phaedrus,” by Plato

Humankind is so easily fooled by appearances.

Smiles, scowls, stares—none are indicative of emotional well-being (or discontent). Similarly, attire and grooming can mask truly one-of-a-kind gems or depravity. Consider, for a moment, the 2007 busking experiment involving world renowned violinist Joshua Bell. On a random winter morning that year, Bell—donning jeans, a T-shirt, and baseball cap—performed Bach’s D minor Chaconne in a Washington, D.C., subway station. The repertoire is among the most difficult pieces of music ever composed.

Conductor Leonard Slatkin expected more than three dozen people (out of 1,000) to recognize Bell’s talent and up to 100 to stop and listen. He also predicted Bell would earn $150 for his efforts.

Slatkin, however, was way off: Bell captured the attention of only seven passers-by that day (out of 1,097) and just 27 gave money. Bell earned a staggering $52.17 for his 43-minute set, with nearly half of that total coming from a person who actually recognized him.

When he repeated the experiment seven years later (2014), Bell dressed better, styled his hair, and announced his performance.

Basically, he looked and played the part of a celebrated violinist this time.

As a result, thousands of people attended his performance.

Alas, appearances are not the most reliable sources of truth, as the medtech industry discovered quickly this year. A healthy American economy, solid corporate growth, and a more cooperative, collaborative partnership with the U.S. Food and Drug Administration failed to abate underlying angst from looming EU regulatory changes, Brexit chaos, slowing sales in China, and possible return of the medical device tax. The usual headwinds didn’t go away, either: Pricing pressures, reimbursement challenges, and cybersecurity issues, among others, only added to industry’s concerns, eventually causing a general sense of uneasiness to seep into corporate boardrooms.

For perspective on these anxieties and other memorable moments of 2019, join Orthopedic Design & Technology on its annual stroll down memory lane. No need to fret, either. The trip shouldn’t be too stressful.

Under the MDR Big Top

It’s been a mad scramble.

Shocking, to say the least.

Medtech’s frenzied sprint toward MDR compliance took on a circus-like ambiance this year as Notified Body shortages, unclear EUDAMED requirements, and product certification backlogs derailed overall conformity efforts.

“European quality assurance and regulatory affairs personnel seem to be overwhelmed by preparations for the new MDR,” Rob Packard, founder/president of the Medical Device Academy, noted in a March 2019 MasterControl whitepaper. “This realization has not quite hit American companies.”

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